Duns Number:028629553
Device Description: VALEO Z 99x99mm x 99mm height 6º Lordosis, textured
Catalog Number
11.009.1605
Brand Name
Valeo Spacer System
Version/Model Number
C
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ODP
Product Code Name
Intervertebral Fusion Device With Bone Graft, Cervical
Public Device Record Key
294072cc-aa93-456e-bbff-49147ea18376
Public Version Date
February 24, 2020
Public Version Number
5
DI Record Publish Date
September 19, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 5 |
2 | A medical device with a moderate to high risk that requires special controls. | 3000 |